What next?
The PAciFY Study was a Phase 3 clinical trial. The study looked at what the effect of a low dose of morphine may have on cough count and the quality of life of patients with idiopathic pulmonary fibrosis (IPF). People who took part were given morphine and a placebo (a tablet that looks just like the morphine but contains no active ingredients) at different times during the study. Forty-three people took part in the 7 week study. This was a relatively short study, so the long term use cannot be spoken for.
Dr Zhe Wu, Clinical Fellow in Interstitial Lung Disease, provided us with an update of the results:
Cough affects approximately 85% of patients with idiopathic pulmonary fibrosis and for some it can be particularly troublesome. The PAciFy Cough trial represents an important breakthrough and is one of the first treatments proven to be effective.
The results showed that treatment with low-dose slow-release morphine sulfate for two weeks led to a 39% reduction in the frequency of cough and improved patients’ quality of life when compared with placebo.
In addition, patients tolerated the treatment extremely well and only one-fifth of subjects developed mild constipation. The good news is that this treatment is already available to patients and is already widely used for other conditions. However, further studies are still needed to assess whether its use remains effective in the long term.
Moving forwards, low dose controlled release morphine could be an effective treatment option for cough in patients with IPF. The next steps for research towards this happening are studies that look at what happens over a longer period of time, to ensure that its long term use is safe and effective.
If you experience challenges associated with cough, please speak to your healthcare team to see if there are management strategies or treatments available to you. There are also ongoing cough research studies that are currently recruiting for participants, please speak to your healthcare team to express your interest or find out more using our online Study Finder.
If you would like to read more about the study results, please take a look at the Lancet journal article.
What next?
The PAciFY Study was a Phase 3 clinical trial. The study looked at what the effect of a low dose of morphine may have on cough count and the quality of life of patients with idiopathic pulmonary fibrosis (IPF). People who took part were given morphine and a placebo (a tablet that looks just like the morphine but contains no active ingredients) at different times during the study. Forty-three people took part in the 7 week study. This was a relatively short study, so the long term use cannot be spoken for.
Dr Zhe Wu, Clinical Fellow in Interstitial Lung Disease, provided us with an update of the results:
Cough affects approximately 85% of patients with idiopathic pulmonary fibrosis and for some it can be particularly troublesome. The PAciFy Cough trial represents an important breakthrough and is one of the first treatments proven to be effective.
The results showed that treatment with low-dose slow-release morphine sulfate for two weeks led to a 39% reduction in the frequency of cough and improved patients’ quality of life when compared with placebo.
In addition, patients tolerated the treatment extremely well and only one-fifth of subjects developed mild constipation. The good news is that this treatment is already available to patients and is already widely used for other conditions. However, further studies are still needed to assess whether its use remains effective in the long term.
Moving forwards, low dose controlled release morphine could be an effective treatment option for cough in patients with IPF. The next steps for research towards this happening are studies that look at what happens over a longer period of time, to ensure that its long term use is safe and effective.
If you experience challenges associated with cough, please speak to your healthcare team to see if there are management strategies or treatments available to you. There are also ongoing cough research studies that are currently recruiting for participants, please speak to your healthcare team to express your interest or find out more using our online Study Finder.
If you would like to read more about the study results, please take a look at the Lancet journal article.
About this study
The cause of cough in pulmonary fibrosis is not fully understood, but researchers around the world are trying to better understand and treat this distressing symptom. The PAciFY Study is investigating whether morphine (a widely used strong painkiller) can reduce the amount IPF patients’ cough and improve their quality of life.
There are many different types of research. These studies might ask participants to test different treatments, devices, or complete questionnaires. Some studies may not require any involvement from people affected by PF, but instead look at cells in a lab environment, animal models, or utilise computer modelling.
A study involving people can be:
- Interventional – participants are given an active treatment decided by researchers. This could be a change in medication or lifestyle (e.g. exercise, diet, complementary wellbeing therapy, or symptom management). These are commonly known as clinical trials.
- Observational – participants are assessed for specific changes over time, but researchers do not alter their standard treatment or care (e.g. questionnaires to understand the impact of symptom, or patient registries that track trends in how disease affects people or the services that are provided).
There are 3 main phases of clinical trials:
- Phase 1 is the earliest stage of research, where there is often a focus on understanding if the treatment is safe or if it causes any side effects.
- Phase 2 still focuses on safety and side effects, but also tries to find out more about what is the best dose.
- Phase 3 often compares the new treatment to existing treatments or lookalike medications.
As drugs or interventions move into the different phases, the number of people taking part will increase. Not all studies will make it to the later phases, especially if the intervention is not found to be safe or effective in phase 1 and 2.
The recruitment aim is the number of people that researcher want to take part in the research study.
What is involved?
This study involves taking morphine and a placebo at different times during the trial. You would need to visit the hospital 3 times, and also be contacted via telephone or video communication twice over the course of 7 weeks.
You would have medical assessments, including blood tests, and be asked to wear a cough monitor and Fitbit device 4 times during the study, each for a period of 24 hours. There are surveys to complete, which will be sent to you via email.
Summary of involvement
7 weeks participation
Taking a drug
Medical assessments
Wearing a cough monitor
Completing surveys
Can I take part?
You may be able to take part if you have received a diagnosis of IPF in the last 5 years and have had a cough for more than 8 weeks.
Unfortunately, you will not be able to take part in this study if you do not have a diagnosis of IPF, or if a measurement of your lung function (known as Forced Vital Capacity, FVC) is less than 45%.
In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see list below). Only the research team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point.
If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.
To find our more about other research opportunities visit our research finder main page.
Diagnosis of IPF within last 5 years
A cough for more than 8 weeks
Aged between 40 and 90
You do not have a diagnosis of IPF
A measurement of your lung function (known as Forced Vital Capacity, FVC) is less than 45%
What difference could taking part make?
Taking part in this clinical trial will help researchers to identify the potential effects of morphine on IPF cough. The study will help to gain greater understanding of the medication and if it has the potential to help people affected by IPF.
Where does the study take place?
Study locations
Royal Brompton Hospital, London
Aintree University Hospital, Liverpool
Patients who are willing to travel to take part in the study may also be eligible to participate. Speak to your clinical team or email pacify@rbht.nhs.uk to find out more.
How to take part
Further information
This page is a summary which provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.
If you have any questions about this research study, please speak to your medical team.
pacify@rbht.nhs.ukThis study is supported by
APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.
Every effort is made to keep these details up to date. If you are aware of any inaccuracies, please email research@actionpf.org